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Human prothrombin complex - Octapharma

Drug Profile

Human prothrombin complex - Octapharma

Alternative Names: 4 Factor Prothrombin Concentrate Complex - Octapharma; 4-Factor PCC - Octapharma; 4F PCC - Octapharma; Four-factor prothrombin complex concentrate; Ocplex; Octaplex; Pronativ

Latest Information Update: 28 Jul 2023

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At a glance

  • Originator Octapharma
  • Class Biological factors; Blood coagulation factors; Proteins
  • Mechanism of Action Factor IX stimulants; Factor VII stimulants; Factor X stimulants; Protein C inhibitors; Prothrombin stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Surgical blood loss
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Surgical blood loss
  • Phase III Haemorrhage

Most Recent Events

  • 26 Jul 2023 Registered for Surgical blood loss in USA (IV)
  • 26 Jul 2023 Human prothrombin complex has boxed warning of arterial and venous thromboembolic complications
  • 26 Jul 2023 Efficacy and adverse events data from a phase III LEX 209 trial in Surgical blood loss released by Octapharma
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